ADA files comments on CMS proposed regulations

'Transfer of value' reports go public in 2013

February 20, 2012

By Craig Palmer, ADA News staff

Washington—The Association urged the Centers for Medicare & Medicaid Services to “clarify” and “limit” proposed regulations that would require public reporting of certain “payments or transfer of value” from pharmaceutical, medical device, biologics and medical supply manufacturers to teaching hospitals and physicians.

As crafted, regulations published Dec. 19, 2011, could adversely affect dental practices, continuing education, research and other professional activities and “discourage financial support of charity care,” the Association asserted in comments on the proposal.

“The proposed rule would also have a disproportionately negative impact on dentistry because few dental items and services are covered under Medicare, Medicaid and CHIP, and yet dentists will be affected if a manufacturer that sells to dentists manufactures even a single covered drug, device, biological or medical supply, because all of that manufacturer’s payments and transfers of value to dentists would be reportable, whether or not there is a relationship to a covered item or service,” the Association said.

The 2010 health reform law requires “applicable manufacturers” covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually certain payments or transfers of value to “covered recipients” including doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors as well as teaching hospitals, which are defined in the proposed rule to include hospitals with accredited residency programs receiving graduate medical education (GME) funds.

“The ADA is primarily concerned that the proposed rule, if implemented in its current form, would have severe and unintended negative consequences for dental practices, professional associations and research institutions, especially in areas in which the proposed rule reaches beyond the provisions of Section 6002 of the Affordable Care Act,” the Association said.

“In particular, the ADA urges the Centers for Medicare & Medicaid Services (CMS) to restrict the definition of 'education’ under the rule so as not to impair the transfer of knowledge that benefits patients and does not undermine the dentist-patient relationship, such as continuing education.”

The 2010 health reform law tasks the Department of Health and Human Services with establishing procedures for manufacturers’ reporting of payment information and making the information available to the public.

The law’s “sunshine” provisions are modeled largely on Medical Payments Advisory Commission (MedPAC) recommendations to Congress for a new regulatory program to address the problem of “at least some” drug and device manufacturer interactions with physicians that “are associated with rapid prescribing of new, more expensive drugs and with physician requests that such drugs be added to hospital formularies” as well as “concern that manufacturers’ influence over physicians’ education may skew the information physicians receive.” The proposed rule says those relationships should be transparent while adding that “transparency does not imply that all - or even most - of these financial ties undermine physician-patient relationships.”

The regulatory proposal “does not fulfill the purpose of the (Affordable Care) Act,” the Association said. “CMS has not demonstrated with respect to dentistry that manufacturer interactions are associated with rapid prescribing of more expensive drugs, devices or supplies, or that dentists’ education skew the information that dentists receive.

“No benefit has been demonstrated with respect to the reporting of payments and transfers of value relating to oral health care, and yet dentists, who often practice in solo and small group practices, will bear the burden of training staff, developing and implementing policies and procedures, keeping records of transfers of value and payments received directly and indirectly from applicable manufacturers, reviewing and requesting correction of reports, paying more for educational programs, paying higher association dues, and contending with the possible reputational damage when perfectly innocuous transactions are listed on a website that the public may perceive as a 'wall of shame’ for practitioners who have inappropriate relationships with industry.”

Covered manufacturers and group purchasing organizations must begin reporting “transfer of value” information to the government March 31, 2013. Payment details are to be made available the public starting Sept. 30, 2013.